The FDA suggests discontinuing the usage of decongestants, that are discovered in lots of chilly medicines

A bottle of Vicks DayQuil cold and flu medicine with phenylephrine is for sale at a CVS Pharmacy store in Hawthorne, California, on September 12, 2023.

Patrick T. Fallon | AFP | Getty Images

The Food and Drug Administration on Thursday proposed ending the use of a common ingredient found in many popular over-the-counter cold and allergy medications.

The agency said a comprehensive review of available data found that the ingredient, oral phenylephrine, does not actually relieve nasal congestion. This came more than a year after FDA advisers unanimously reached the same conclusion.

Based on the data, “we are taking this next step in the process to suggest the removal of oral phenylephrine because it is not effective as a nasal decongestant,” Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, released in a statement.

The FDA said the proposed order is not based on safety concerns and is not yet final, meaning companies can still market over-the-counter medications containing oral phenylephrine for now. But a final decision would force pharmacies to clear their shelves of hundreds of products that contain oral forms of the ingredient, which is found in versions of drugs such as NyQuil, Benadryl, Sudafed and Mucinex.

Last year, CVS said it has already moved to remove certain medications containing oral phenylephrine from the market.

A final order would also affect drug manufacturers such as Procter & GambleBavarian and Johnson & Johnson Spin off Kenvue to reformulate many of their oral cold and allergy products.

Phenylephrine is thought to relieve nasal congestion by reducing the swelling of the blood vessels in the nasal passages. Without the market for oral phenylephrine, patients will likely look for spray versions of the drug or other medications with different ingredients that are not impacted by the FDA's decision.

Retail stores like CVS and Walgreens could also suffer a setback: These stores sold 242 million bottles of phenylephrine-containing drugs in 2022, representing nearly $1.8 billion in sales, according to a presentation from FDA staff last year.

The FDA could specifically revoke the drug's over-the-counter label as “generally recognized as safe and effective.” The designation, typically used for older drugs, allows drugmakers to include an ingredient in over-the-counter products without having to submit an FDA application.

Last year's meeting of FDA advisers was inspired by researchers at the University of Florida, who petitioned the agency to remove phenylephrine products from the market based on studies that showed they did not work in patients with colds and allergies had better effects than placebo pills.

The same researchers also questioned the drug's effectiveness in 2007, but the FDA allowed the products to remain on the market pending further study.

However, in briefing documents released before the panel meeting last year, FDA staff concluded that oral formulations of phenylephrine do not work at standard doses or even higher doses. Staff said only a very small amount of phenylephrine actually reaches the nose to relieve congestion.

Representatives from the Consumer Healthcare Products Association, a group that represents over-the-counter drug makers, presented no new evidence during last year's meeting that could refute FDA staff's conclusion on phenylephrine.

However, the group argued that removing oral phenylephrine from the market would place a significant burden on consumers.

The group shared a survey that found one in two households in the U.S. used an oral decongestant in the last year. People have also been found to prefer oral decongestants over nasal spray by a 3 to 1 ratio.

Phenylephrine became the main decongestant in over-the-counter cold and allergy medications in 2006 when sales of another decongestant, pseudoephedrine, were restricted in the United States

Pseudoephedrine was brought behind the pharmacy counter because it can be abused to make methamphetamine, a highly addictive stimulant that affects the central nervous system.